MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Necrosis (1971); Discharge (2225); Reaction (2414); No Code Available (3191)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: procedure name: total hip arthroplasty;.Procedure date: (b)(6).How the device was used (what layer of tissue and how many layers applied)? prineo 22 was applied topically over a 4 layer closure (joint capsule, fascia, subcutaneous, subcuticular).Location and incision size of product application? hip.Incision was roughly 6 inches from apex to apex.What prep was used prior to prineo use? skin was cleaned with sterile saline applied to a surgical sponge.Was the prep allowed to dry prior to prineo mesh application? yes.Completely dry.Please describe how the adhesive was applied on the tape? prineo 22 was applied in my presence with my instruction in complete accordance with oem protocol.Was the mesh placed over the entire length of the incision? yes.The mesh extended at least 1cm beyond both apexes.Was the dermabond liquid adhesive placed to cover the entire length of the mesh? yes.The mesh was thoroughly covered.Edge to edge.Corner to corner.No dry spots.Did the prineo mesh extend beyond the patient incision? yes.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? yes.Sterile saline.Incision and surrounding area were completely dry prior to application.Was the skin prep solution wiped off and let dry before applying adhesive? yes.Was a dressing placed over the incision? if so, what type of cover dressing used? no.Date of reaction: reaction was noticed by the md at the patient¿s post-op follow up appointment on (b)(6).What does the reaction look like? please provide details.No blistering.Notable fluid build-up beneath mesh requiring aspiration.How large of an area does the reaction cover? no definitive information at this time.Do you have any pictures of the reaction? none available.What was done to address the reaction? no definitive information available at the present time.What type of medication? dose? when (date) administered? ??.Was the product removed? was another method used to close the incision? product was not removed.Was the site cultured? if so, what bacteria were identified? no information available.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no information available.Is the patient hypersensitive to pressure sensitive adhesives? no information available.Were any patch or sensitivity tests performed? no information available.Product code and lot number involved: clr222us, kcj827.What is the physicians opinion of the contributing factors to the reaction? possible patient allergy.Possible interaction with exparel.Possible product issue.What is the most current patient status? no information available.Is the product or representative sample (product from the same lot number) available for evaluation? yes.Patient demographics: initials / id; age or date of birth; bmi ; gender: no information available.Patient pre-existing medical conditions (ie.Allergies, history of reactions): no information available.For female patients ask if they were exposed to similar products, such as artificial nails: no information available.The saline used to clean the incision prior to application may/may not have contained epinephrine or bacitracin.Additional information was requested and the following was obtained: blister area, still oozy and exudative, removed mesh, some goo under the mesh on incision line, incision line has black eschar, narrow 1/8¿ wide necrotic, not wet the single complaint was reported with multiple events.Attempts are being made to obtain further information.To date no further response has been received.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent total hip arthroplasty on 11/29/2016 and topical skin adhesive was used.The topical skin adhesive was applied over a 4-layer closure of joint capsule, fascia, subcutaneous and subcuticular.Prior to application of the topical skin adhesive, the skin was cleaned with sterile saline applied to a surgical sponge and was completely dry.The saline used to clean the incision prior to application may or may not have contained epinephrine or bacitracin.An exparel injection was used in the subcutaneous tissue and closure was done with barbed suture in fascia and subcuticular layer.Hip incision was approximately 6 inches from apex to apex and mesh was placed over the entire length of the incision.The patient experienced a reaction post-operatively on (b)(6) 2016 with notable fluid build-up beneath mesh requiring aspiration.The patient may possibly have blistering area, oozy and exudative, with black eschar, narrow 1/8¿ wide necrotic, not wet and may have had the mesh removed.The physician opined a possible patient allergy and possible interaction with exparel.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 01/19/2017.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6226453
• MDR Text Key: 63973325
• Report Number: 2210968-2017-30091
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2018
• Device Catalogue Number: CLR222US
• Device Lot Number: KCJ827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXPAREL, STRATAFIX SYMMETRIC SUTURE
• Patient Outcome(s): Required Intervention